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3 Breast Lesions Discovered to have Low Cancer Rate in Trial

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According to data gathered from a multi-site imaging trial including more than 2,600 women, researchers say breast lesions categorized as 'probably benign' on additional screening ultrasound could be re-assessed with imaging in one year, leading to a decrease in patient anxiety, follow-up exams and superfluous biopsies. Findings of the study have gone on to be published online in the journal Radiology.

During the course of the study, researchers examined data from the American College of Radiology Imaging Network (ACRIN) trial 6666, in which both annual mammography and ultrasound screenings were carried out on women with dense breasts at 21 different locations around the country. Ultrasound is gradually being used as a supplement to screening mammography because it has the ability to identify breast cancers that would otherwise go undetected with mammography, especially in dense breasts.breast lesion

"Supplemental ultrasound screening increases cancer detection beyond mammography alone, but may also result in an increased number of additional tests. Both screening ultrasound and screening mammography have similar issues: to find breast cancers, a large number of biopsies must be performed, most of which turn out to be negative,” said lead researcher and professor of radiology at the Northeast Ohio Medical University in Youngstown, Ohio, Richard G. Barr, M.D., Ph.D.

Barr and his peers examined the trial’s ultrasound-detected lesions determined as most likely benign or category 3 of the Breast Imaging-Reporting and Data System (BI-RADS), a standardized system of evaluating breast lesions and their likelihood of malignancy based on appearance, to determine the prevalence and malignancy rate of these lesions.

Guidelines point out that BI-RADS 3 lesions should be observed for any wary changes with supplemental imaging at time periods of six, 12, and 24 months.

"BI-RADS 3 lesions are common on screening ultrasound and often lead to unnecessary biopsies and additional imaging, causing substantial cost and anxiety for patients. We wanted to study these BI-RADS 3 lesions to look for ways to perform fewer biopsies without missing breast cancers,” said Barr.

Researchers investigated the screening ultrasound tests and follow-up data of 2,662 trial participants enrolled between 2004 and 2006. From the 2,662 women, 519 had a total of 745 BI-RADS 3 lesions, representing 25 percent of all ultrasound-detected lesions in the study.

From the 745 BI-RADS 3 lesions, six were malignant for a total malignancy rate of 0.8 percent. The median size of the detected cancers among the BI-RADS 3 lesions was 10 millimeters.

During the six-month follow-up interval imaging, shady changes were observed in only one of the 745 BI-RADS 3 lesions. At 12-month follow-up imaging, suspicious changes were observed in a second BI-RADS 3 lesion, revealing an invasive breast cancer that had not yet extended passed the breast.

"As a result of the low malignancy rate of BI-RADS 3 lesions and the low rate of suspicious changes at six-month follow-up imaging, yearly follow-up for these lesions may be appropriate. The cancers detected due to changes at one year had not spread beyond the breast, with similar prognosis if the lesion was biopsied on initial detection,” said Barr.

Barr noted that extending the follow-up imaging interval from six to 12 months for BI-RADS 3 lesions detected by screening ultrasound would significantly lower the number of follow-up examinations and biopsies performed.

The researchers also discovered that women included in the study with BI-RADS 3 lesions were more probable to be younger than 50 years of age, of Hispanic or Latino ethnicity and pre-menopausal.

As of now Barr is conducting further studies on ultrasound screening and research on the use of elastography, an advanced method that enables distinction from benign and cancerous lesions.


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